This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.Based on the results of the investigation, physical stress was applied to the insertion section during user handling and caused the coating to peel.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: "3.3 inspection of the endoscope 4 inspect the external surface of the entire insertion section, including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects." olympus will continue to monitor field performance for this device.
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